HICHEM GLUCOSE/HK REAGENT KIT

HICHEM GLUCOSE/HK REAGENT KIT is an FDA 510(k)-cleared medical device (K960084) manufactured by Hi Chem, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 1996. Regulation: 8.